510(k) K960657
K960657 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on Apr 29, 1996. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 1996
- Date Received
- Feb 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)